Neuronaute Touchproof Adapter 1001-15024-US

GUDID 03615220003846

The Touchproof Adapter is an accessory of the Neuronaute IceCap, It's composed of a cable with sub-D25 female connector on one edge and 21 touchproof on the other edge. It will allow to connect the Neuronaute IceCap to a compatible EEG recorder through the touchproof connection.

BIOSERENITY MEDICAL DEVICES GROUP

Electroencephalographic electrode cap, single-use

• Primary Device ID: 03615220003846
• NIH Device Record Key: 976194b8-a3cf-4b7c-96bb-b4d644bc3ca5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neuronaute Touchproof Adapter
• Version Model Number: 1001-15024-UN
• Catalog Number: 1001-15024-US
• Company DUNS: 281224773
• Company Name: BIOSERENITY MEDICAL DEVICES GROUP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03615220003846 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223644

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-25
• Device Publish Date: 2025-04-17

Devices Manufactured by BIOSERENITY MEDICAL DEVICES GROUP

• 03615220003846 - Neuronaute Touchproof Adapter: 2025-04-25The Touchproof Adapter is an accessory of the Neuronaute IceCap, It's composed of a cable with sub-D25 female connector on one edge and 21 touchproof on the other edge. It will allow to connect the Neuronaute IceCap to a compatible EEG recorder through the touchproof connection.
• 03615220003846 - Neuronaute Touchproof Adapter: 2025-04-25 The Touchproof Adapter is an accessory of the Neuronaute IceCap, It's composed of a cable with sub-D25 female connector on one e
• 03615220003952 - Neuronaute® IceCap Neonate (M): 2025-04-25 The IceCaps are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurol
• 03615220003969 - Neuronaute® IceCap Neonate (S): 2025-04-25 The IceCaps are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurol
• 03615220003976 - Neuronaute® IceCap Neonate (XS): 2025-04-25 The IceCaps are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurol
• 03615220003471 - Neuronaute - IceAdapter: 2025-04-18 Neuronaute - IceAdapter is a cable that enables to plug the Neuronaute IceCap electrodes with another DB25 cable and be connecte
• 03615220003679 - Neuronaute Plus Touchproof Extender: 2024-05-30
• 03615220003983 - Neuronaute Plus- Holding Band: 2024-03-29
• 03615220003655 - Neuronaute Plus - DB25 Extender: 2024-02-28